- Sumitomo Pharma (Tallahassee, FL)
- …a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
- Lilly (Indianapolis, IN)
- …enable or advance drug development and manufacturing + Author sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for ... of customer focus and collaboration and be a strong scientific contributor. ** Regulatory Compliance** + Perform work in full compliance with assigned curricula and… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Organizational Overview:** CMC Project Management is responsible for leading the creation, development, communication ... and implementation of integrated CMC plans for assets from portfolio entry to global...goals (working closely with asset leadership, PPM, clinical/medical, and regulatory partners). + Lead the creation, development, communication and… more
- University of Maryland, Baltimore (Baltimore, MD)
- …This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and Controls ( CMC ); Clinical Research; ... fulfill the faculty position of Instructor (non-tenure track) for the MS in Regulatory Science within the Department of Pharmaceutical Sciences. The MS in … more
- AbbVie (South San Francisco, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie has a long and rich history of ... art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …of subject matter experts to orchestrate and execute, within the network, CMC potency and impurity strategy and structure-function understanding of product quality ... functions. This role is responsible for managing and delivering key CMC potency and impurity milestones from pre-clinical through commercial stage biotherapeutics.… more
- Cambrex High Point (Waltham, MA)
- …+ Author and review process development reports, batch records, validation protocols, CMC documentation (eg, Module 3), and regulatory filings (IND, NDA). ... + Collaborate cross-functionally with QA, QC, regulatory , and supply chain to ensure technical alignment and compliance. + Troubleshoot scale-up issues, support… more
- Takeda Pharmaceuticals (Boston, MA)
- …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. + Represents CMC on cross-divisional governance and development teams while providing strategy… more
- Adecco US, Inc. (Cambridge, MA)
- **Technical Leader, MSAT CMC Development** **Location:** Cambridge, MA (Onsite) **Pay** : 60-67.5/hr depending on experience and background Adecco Healthcare & Life ... Leader** to join the **MSAT Synthetics and Oral Solids** group, supporting ** CMC development and pharmaceutical technical activities** for new R&D compounds, Life… more
- Takeda Pharmaceuticals (Lexington, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more